BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION? MONTAGE? MRI

    MDR report key: 23583262 · Received November 18, 2025

    Report

    Report Number
    3006630150-2025-10517
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    May 13, 2025
    Report Date
    January 30, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN THE PAST FEW MONTHS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8216700. MODEL: SC-8216-70. SERIAL: (B)(6). BATCH: 7051867. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN THE PAST FEW MONTHS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216700, MODEL: SC-8216-70, SERIAL: (B)(6), BATCH: 7051867, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING FREQUENT IMPLANTABLE PULSE GENERATOR (IPG) CHARGING AND HAD IMPEDANCES ON CONTACT. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) REPLACEMENT PROCEDURE. PATIENT IS DOING WELL POSTOPERATIVELY. UNABLE TO RETRIEVE EXPLANTED ITEMS PER PHYSICIAN PROTOCOL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING FREQUENT IMPLANTABLE PULSE GENERATOR (IPG) CHARGING AND HAD IMPEDANCES ON CONTACT. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) REPLACEMENT PROCEDURE. PATIENT IS DOING WELL POSTOPERATIVELY. UNABLE TO RETRIEVE EXPLANTED ITEMS PER PHYSICIAN PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2326128 PRECISION? MONTAGE? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 364245 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention